We translate our deep understanding of time-dependent biology into the development of impactful medicines that are designed to be well-timed to ease the burden of disease.

It’s time…

for medicines to work in sync with you

At Adamas Pharmaceuticals, Inc., we seek to redefine the treatment experience for patients suffering from chronic neurological diseases. Our vision is grand, our goal bold: to create and commercialize a new generation of medicines intended to lessen the burden of disease on patients, caregivers and society. With a new commercial medicine and robust pipeline of investigational programs focused on meaningfully differentiated treatment options for patients, we are well on our way. Our therapeutic targets include a broad range of neurologic diseases, including Parkinson’s disease, multiple sclerosis, epilepsy and Alzheimer’s disease.

Our treatment innovations stem from a deep scientific understanding of time-dependent biology – the deliberate mapping of disease patterns and drug activity – along with a goal to meaningfully increase the efficacy of known molecules without compromising tolerability. This approach is designed to ensure that our medicines fit within, rather than define, people’s daily lives. Our goal is to develop medicines that are timed for the benefit of patients.

Our Approach

Sources of Time-Dependent Biology

We are using time to fundamentally change the treatment experience of people with chronic neurologic diseases. We search for time-dependent patterns in diseases to reshape the timing of medicines and drive significant clinical outcomes for people in need.

Our exploration revolves around the knowledge that biological pathways and responses involve elements of time. We first map complex disease and drug activity patterns. From there, we design medicines with profiles that match the pattern of disease activity to drug levels to achieve therapeutic drug concentrations when needed most. We strive to create medicines with more significant and durable clinical effect without compromising tolerability. Our medicines are designed and developed to be timed to benefit patients.

Disease patterns

Due to the underlying biology, the occurrence and severity of disease symptoms may change throughout the day

Initial rate-of-rise in drug concentration

The speed at which drug concentration increases in the body may drive tolerability and efficacy responses

Timing of drug response

Matching the timing of drug levels to disease patterns may increase treatment benefit

Pathway sequence

Drugs acting sequentially along a pathway may produce an outcome that is greater than the sum of the individual effects (synergy)

Board of Directors

Gregory T. Went, PhD

Founder, Chairman and Chief Executive Officer

Dr. Went is the founder, chairman, and CEO of Adamas Pharmaceuticals and has guided the company’s growth since its inception in 2000. Dr. Went developed the original scientific approach, based upon the understanding and modeling of time-dependent biological phenomena. He has steered Adamas through the licensing of assets related to Namenda XR and Namzaric to Forest Laboratories (now Allergan), the company’s IPO, and steered the company through the development of Gocovri and the commercial launch of a new medicine for patients with Parkinson’s disease. Prior to Adamas, Dr. Went co-founded CuraGen Corporation in 1992, one of the first genomics companies, where he served as executive vice president and director. He has served on the board of directors of Angelica, Parallele Biosciences, and Tethys Biosciences.

Dr. Went has published in the fields of catalysis, spectroscopy, DNA sequencing, gene expression profiling, neuroscience, influenza, and neurology. An inventor with more than 70 issued and pending patents, he received his PhD in chemical engineering from the University of California, Berkeley, his BS in chemical engineering from Carnegie Mellon University, and completed additional post-doctoral work at Cornell University.

Alfred G. Merriweather

Chief Financial Officer

Mr. Merriweather joined the company in June 2017. Before coming to Adamas, he was chief financial officer at RainDance Technologies, Inc. Prior to RainDance, he served as chief financial officer of Verinata Health, Inc. and as chief financial officer of Celera Corporation. Mr. Merriweather previously spent more than 25 years in senior financial positions at several private and public life science companies, including Monogram Biosciences, Inc. and Laserscope. Mr. Merriweather received a bachelor’s degree from the University of Cambridge in the United Kingdom.

Richard A. King

Chief Operating Officer

Mr. King joined the company in April 2017. Before coming to Adamas, he was COO at The Scripps Research Institute. He previously served as president and CEO of AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical company developing new pain medications. Prior to AcelRx, Mr. King was president and COO of the biotechnology company Tercica, Inc. (later acquired by the Ipsen Group), where he was instrumental in the commercial launch of Dysport, Somatulin Autogel and Increlex. He also previously served as executive vice president of commercial operations at Kos Pharmaceuticals, Inc., where he oversaw the growth of Niaspan® (niacin extended-release) and the launch of Advicor® (niacin extended-release/lovastatin). Additionally, Mr. King was senior vice president of commercial operations at Solvay and vice president of Commercial Operations at Unimed, where he launched AndroGel®(testosterone gel). He received a BSc in chemical engineering from the University of Surrey in the UK and an MBA from the Manchester Business School in the UK.

Rajiv Patni, MD

Chief Medical Officer

Dr. Patni joined Adamas as chief medical officer in June 2015. Dr. Patni brings more than 15 years of global drug development experience across multiple therapeutic areas as well as extensive knowledge of the drug approval process. Prior to joining Adamas, Dr. Patni served as chief development officer at Ocera Therapeutics. Earlier in his career, he served as SVP (chief medical officer) at Actelion US Pharmaceuticals, executive director/VP (product lifecycle team leader, therapeutic area head) at Roche Pharmaceuticals, and senior medical director (development team leader) at Novartis and Pfizer Inc. Dr. Patni earned a BS from the City University of New York Sophie Davis School of Biomedical Education (accelerated BS/MD Program) and an MD from the Mount Sinai School of Medicine. He completed his residency and fellowship in internal medicine and cardiology at the Albert Einstein College of Medicine in New York, where he was also an attending physician.

Jennifer J. Rhodes

Ms. Rhodes joined Adamas as general counsel and corporate secretary in April 2016, and was subsequently appointed chief compliance officer and chief business officer in August 2016 and January 2017, respectively. She previously served as general counsel at Medivation, Inc., where she was responsible for Medivation’s legal matters and also served as corporate secretary and as chief compliance officer. Before Medivation, Ms. Rhodes was an assistant general counsel at Pfizer Inc., where she supported the US primary care business and its primary care medicines development group and served as a global product lead for Pfizer Inc.’s primary care medicines. Prior to joining Pfizer, Ms. Rhodes was an associate in the regulatory law and international trade practice areas at Weil, Gotshal & Manges, LLP. She also served as a law clerk for Chief Judge Gregory A. Carman on the United States Court of International Trade. Ms. Rhodes received a JD from Wake Forest University School of Law and a BA in economics from Newcomb College of Tulane.

Christopher B. Prentiss

Chief Accounting Officer

Mr. Prentiss joined the company in April 2015 as VP, Finance and Controller before becoming the Chief Accounting Officer of Adamas in September 2017. Before coming to Adamas, he was most recently VP, Finance and Controller at InterMune, Inc., a biotechnology company, until its acquisition by Roche. Prior to that, Mr. Prentiss was the Controller at Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company and held the same position at MannKind Corporation, a biotechnology company, as well as a variety of other finance roles. Prior to joining MannKind, Mr. Prentiss was a Senior Manager at KPMG LLP in the assurance practice. Mr. Prentiss received a Bachelor’s of Science degree in Accounting from Loyola Marymount University, and a Masters of Business Administration from Indiana University. Mr. Prentiss is a CPA licensed in California.

Michael F. Bigham

Mr. Bigham currently serves as chief executive officer and chairman of the board of directors of Paratek Pharmaceuticals, Inc. He has more than 25 years of senior leadership experience in the biopharmaceutical industry. From 2003 to 2015, Mr. Bigham was a partner at Abingworth LLP, an international investment group dedicated to life sciences and healthcare. Earlier in his career, he served as chairman and chief executive officer of Coulter Pharmaceuticals up until the company’s acquisition by Corixa. Mr. Bigham currently is a member of the board of directors of InMediata and has held several directorships, including Avila Therapeutics, Magellan Biosciences, Portola Pharmaceuticals, Supernus Pharmaceuticals, Avedro, and Valeritas. He received his BS from the University of Virginia and his MBA from Stanford University.

Mardi C. Dier

Ms. Dier serves as Executive Vice President and Chief Financial Officer of Portola Pharmaceuticals since November 2013 after joining the company in August 2006. Previously, she served as Vice President of Investor Relations at Chiron Corporation from 2003 until its acquisition by Novartis Pharmaceuticals in April 2006. Prior to joining Chiron, she served as a Director in the West Coast investment banking practice at Prudential Securities, where she focused on biotechnology and other life sciences companies. Ms. Dier was previously at KPMG Peat Marwick in the audit department. She holds a B.S. in biology from Stanford University and an M.B.A. from The Anderson School at the University of California, Los Angeles. In 2013, Ms. Dier was recognized as one of the most influential Bay Area business women by the San Francisco Business Times and was a finalist for its Bay Area CFO of the Year Award.

Martha J. Demski

Ms. Demski has more than 30 years of experience in the fields of finance and biotechnology. She is on the board of directors of Chimerix, Inc., where she chairs the audit committee and serves on the nominating and governance committee. She also chairs the audit committee and serves on the compensation committee at Neothetics, Inc. Previously, Ms. Demski served as senior vice president and chief financial officer of Ajinomoto Althea, Inc., as well as interim chief operating officer and chief financial officer of the Sidney Kimmel Cancer Center. She has also served as chief financial officer of Vical Incorporated, where she was responsible for multiple private and public financings, including the company’s initial public offering. Additionally, Ms. Demski also has more than 13 years of banking experience with Bank of America and US Trust. She holds an MBA from The University of Chicago Booth School of Business and a BA from Michigan State University. In 2014 Ms. Demski was awarded the CFO of the Year Award of Distinction by the San Diego Business Journal. In 2017 Ms. Demski was honored as the Director of the Year in Corporate Governance by the San Diego Corporate Directors Forum.

William Ericson, JD

Mr. Ericson is a managing partner of Mohr Davidow Ventures and a managing director of Wildcat Venture Partners. He currently serves on the board of directors of Pacific Biosciences and Rocket Fuel, as well as the boards of a number of privately held software and healthcare companies. Mr. Ericson received his BSFS from Georgetown University of Foreign Service and his JD from Northwestern University School of Law.

Ivan Lieberburg, MD, PhD

Dr. Lieberburg is currently a member of the Tavistock Group, a private equity firm, where he concentrates on healthcare and life sciences investment opportunities. Prior to joining Tavistock in 2009, Dr. Lieberburg was employed at Elan Corporation, plc for 22 years, where he most recently served as executive vice president in the Corporate Office of Technology, and chief medical officer. Prior to joining Elan (formerly Athena Neurosciences, Inc.) in 1987, Dr. Lieberburg held faculty positions at Albert Einstein School of Medicine and Mount Sinai School of Medicine. He holds a PhD from Rockefeller University and an MD from the University of Miami. Dr. Lieberburg is the author of more than 100 publications and an inventor on 29 patents and patent applications.

John MacPhee, MPH

Mr. MacPhee serves as chief executive officer of The JED Foundation, a nonprofit organization that exists to reduce the risks of substance abuse, self-harm, and suicide and to help young adults thrive. Prior to JED, he served as executive vice president of Par Pharmaceutical and president of Par’s Strativa Pharmaceuticals division, where he oversaw commercial operations, clinical development, medical affairs, and business development. Previously, he worked at Forest Laboratories, where he led the launches of Celexa® (citalopram), Lexapro® (escitalopram), and Namenda® (memantine HCl). Mr. MacPhee also serves as a board member for Bottom Line, a nonprofit organization that provides guidance counseling to disadvantaged urban youth to help them get into college and graduate. He earned a BA from Columbia College, an MBA from New York University, and an MPH from Columbia University.

David L. Mahoney

Mr. Mahoney is a private equity investor and currently serves on the board of directors of Symantec Corporation, Corcept Therapeutics, and Mercy Corps, and as a Trustee of the Schwab Mutual Funds and SFMOMA. Previously, Mr. Mahoney acted as co-chief executive officer of McKesson HBOC, Inc. (now McKesson Corporation) and as chief executive officer of McKesson LLC from July 1999 to February 2001. He joined McKesson in 1990 as Vice President for Strategic Planning and managed the company’s relationships with the pharmaceutical industry. Prior to joining McKesson, Mr. Mahoney was a principal with McKinsey & Company from 1981 to 1990. Mr. Mahoney is an honors graduate from Harvard Business School and Princeton University.

Our Core Values

At Adamas, the principles by which we do business and interact on behalf of our patients reflect who we are, how we think, and how we engage in the important work we do. As a pillar of our company culture, we show up each day with an energy and enthusiasm indicative of the importance of our work and the decisions we make that impact others.

Passionate
about what we do and how we do it

Expect the best work of ourselves and others
respect, challenge and support

We are in this together
shared goals, open communication, and collaboration

Our Responsibility

Adamas takes its role as a developer and manufacturer of pharmaceutical products seriously, placing patient well-being first in all we do and deliver. We demonstrate our commitment to stakeholders by practicing our core values and adhering to the highest level of integrity and quality.

Integrity

Adamas operates with an unwavering commitment to the highest ethical standards in healthcare, upholding all applicable laws, regulations, and industry codes. Our practices, policies, and procedures, including our Code of Business Conduct and Ethics, reflect our commitment and it is our expectation that every Adamas employee, consultant, vendor, supplier, and agent embody this standard of ethics.

Quality

At Adamas, we measure quality across all company activities, procedures and clinical trials through a rigorous approach to data collection and collaboration.

We ensure that all of our people follow best practices and that our medicines reflect the primary responsibility we have to protect the health and well-being of clinical trial volunteers and patients who are prescribed our medicines.

We encourage the reporting of any known or suspected violations of law, regulation, our policy, procedure, or standard operating procedure associated with our business activities.

If you are aware of a situation that you believe may involve such violations, please report this information to the Legal and Compliance Department or the Chief Compliance Officer at compliance@adamaspharma.com.

You can also reach the Adamas “Speak Up” Helpline at 1-844-644-4174 or online at www.adamaspharma.ethicspoint.com. Calls can be made anonymously, except as otherwise required by law.

Partner with Us

Are you curious about our approach to time dependent biology and the opportunities we are pursuing to develop differentiated medicines for chronic neurologic diseases? Please contact us. We are always interested in exploring new opportunities to enhance the value of our products, including partnerships and collaborations. To inquire, please click here to contact us.

Clinical Program Director

The Clinical Program Director plays a critical role in developing and managing the clinical operations team and infrastructure for a given project(s). This position will provide strategic and operational leadership and drive the planning and execution for assigned clinical trials with direct responsibility for time, cost, quality and risk mitigation. This position is based in Emeryville, CA and reports to the Vice President, Clinical Operations.

Responsibilities:

Works closely with senior management & key stakeholders to assist with the overall clinical strategy consistent with Project Team goals;

Leads the clinical trial(s) team with overall responsibility for the tactical implementation of trial timelines, study timelines, milestones and budget in collaboration with the Project Team; May be the clinical sub-team leader for a given program.

Develops study management plans, recommends team roster assignments and team accountability (with approval from appropriate department head for the cross-functional trial team members)

Reviews and qualifies investigational sites for participation in trials

Manages and oversees all monitoring of clinical studies (internal and external)

Collects and archives all documents for inclusion in the Trial Master File

Reviews and finalizes clinical study reports and other applicable reports authored by clinical team members for submission to regulatory agencies

Ensures appropriate systems for inventory, tracking/accountability (handling, storage, return, documentation, etc.) of investigational product are in place and in compliance with all applicable regulations

Serves as primary internal and external clinical operations project contact (eg CRO or vendor) to ensure communication is maintained and timelines are achieved;

Assists with the development of clinical SOPs in accordance with ICH and GCP guidelines

Selects, trains and mentors appropriate team members to ensure tasks are completed on time and within budget. Responsible for line management of junior staff (Clinical Research Associates, Clinical Trial Assistant, etc.);

Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.

Qualifications:

Minimum of a Bachelor’s degree in a relevant scientific discipline, Graduate Health or Scientific degree preferred;

Minimum of 10 years of related clinical management experience (CRO, biotech or pharmaceutical company) or equivalent combination of education, training and experience;

Previous experience of line management with a proven record of employee development;

In depth knowledge of and skill in applying pharmaceutical regulatory requirements and the impact on development of clinical trials, specifically, knowledge of 21 Code of Federal Regulations Title 21 Parts 11, 50, 54, 56, 312, 314; International Conference on Harmonization Guidelines E6 (Good Clinical Practice: Consolidated Guidance), E2A, E8 and Guidelines from other Regulatory Authorities pertinent to planned studies;

Thorough knowledge of planning, implementing, and managing single and multi-center clinical trials is required. CNS experience is preferred and international study experience is a plus;

Able to break down assigned work into manageable process steps that ensures maximum efficiency of self and others. Can effectively manage multiple and changing priorities;

Strong written and verbal communication, interpersonal, problem solving and negotiation skills. Can prepare appropriate documentation and materials in final draft that are clear and convey the desired message;

Adept at cross-functional team management and strategic program planning;

Proven ability to organize, take initiative and follow-up independently;

Excellent presentation skills: ability to present to all levels (internal and external);

Proven organizational skills; ability to manage multiple priorities and work under pressure;

Ability to travel as needed, up to 20%

Successful experience in fast-paced entrepreneurial environment;

Fit with Adamas culture and values.

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Publications and Scientific Communications

The Director, Publications and Scientific Communications, is responsible for all the R&D deliverables: including the scientific platform and its derivatives: abstracts, posters, manuscripts, and other collateral (e.g., videos, master slide decks). This position reports to the Vice President, Research and is based in Emeryville, CA.

Responsibilities:

Owns all scientific and medical communication deliverables including creation and maintenance of scientific platforms for therapeutic areas as well as master slide decks /collaterals

Support Clinical Operations, Clinical Research, Research, and Medical Affairs by the creating and maintaining models and simulations of data for various deliverables.

Ensures compliance with corporate policies and procedures, as well as, US healthcare
laws and regulations.

Qualifications:

Advanced degree in scientific or clinical discipline, or Bachelor’s degree with equivalent
work experience;

Minimum of 6-8 years’ progressive experience in the pharmaceutical industry in medical affairs, medical communications, medical information, clinical development or similar area;

Proven track record of successful medical communication in prior biopharmaceutical companies; ideally in a small company environment; can easily point to examples;

Demonstrated ability to comprehend complex scientific data and concepts and devise approaches to communicate effectively to a variety of audiences

Established network of medical communication vendors;

Successful experience in fast-paced entrepreneurial environment;

Fit with Adamas culture and values.

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Director, Regulatory Affairs Development

The Director, Development Regulatory Affairs ensures that regulatory expertise is provided for all investigational drug development programs to enable product registration. The incumbent will be an effective collaborator with the research, clinical research, clinical operations, pharmaceutical development, and quality departments. This position reports to the Vice President, Regulatory Affairs and is based in Emeryville, CA.

Responsibilities:

Owns creation of development regulatory strategy for non-clinical, clinical, and CMC, across the product lifecycle (IND to NDA to label negotiation). Practically interprets and applies relevant health authority guidance documents. Maintains awareness of relevant labeling precedents. If precedent does not exist, then defines a potential regulatory path

Serves as the primary liaison with FDA and other health authorities; leads all interactions; functions as regulatory liaison with contract research organizations (CROs); prepares IMPD to support international CTA submissions

Is a standing member of all project teams; chairs all regulatory sub-teams

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Executive Assistant to the CFO

As a member of the General and Administrative team, the Executive Assistant to the CFO is responsible for providing comprehensive administrative support to the Chief Financial Officer (CFO), the Chief Accounting Officer (CAO), and the Head of Investor Relations. The position will work in partnership with the Executive Assistant to the CEO, will work closely with the internal administrative team and will report to the Chief Financial Officer in Emeryville, CA.

Responsibilities:General Administrative Support

Provides general administrative support to the CFO, CAO and Head of Investor Relations and backup support to the Executive Admin for the CEO;

Supports the CFO, CAO and Head of Investor Relations in maintaining a culture of operational excellence;

Participates as a member of the Adamas Administrative team, manages administrative projects as assigned by the Executive Assistant to the CEO, and provides backup support to other administrative team members as requested;

Complies with corporate policies and procedures, as well as, US healthcare laws and regulations.

CFO, CAO and Investor Relations Support

Conducts professional dialog with, and represents the CFO and the Company, to members of the board of directors, partners and public company investors and analysts, as needed;

Assists with the maintenance of the IR database and provides support for IR analyses and activities;

Under the guidance of the CFO, manages the access to materials by board members for meetings of the board of directors and committees

Under the guidance of the CFO, supports scheduling and material management for meetings of the Executive Team

Qualifications:

Bachelor’s degree or equivalent experience. Minimum of 10 years of executive administrative including support to CFO; Experience at public companies is required and with investor relations is strongly desired;

Able to handle confidential information and records with the utmost of discretion;

Proficiency with all Microsoft Office applications (Word, Excel and Powerpoint);

High attention to detail required with a focus on ensuring deadlines are met and accurate records are kept;

Demonstrated ability to relate well to others; establishes and maintains effective relationships with internal and external parties; easily gains trust and respect;

The ability to handle multiple projects and adaptable to changing priorities;

Excellent judgment and composure;

The ability to work independently, be flexible and have strong organizational skills;

Good problem-solving skills, as well as, the ability to make suggestions to improve efficiencies;

Successful experience in a fast-paced entrepreneurial environment;

Fit with Adamas’ culture and values.

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Medical Science Liaison / Sr. Medical Science Liaison - Dallas, TX

The Medical Science Liaison is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is field based with a corporate headquarters in Emeryville, California.

Responsibilities:

Provides project leadership and management on field team and functional area initiatives;

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

The Medical Science Liaison is responsible for conducting medical/scientific interactions and for supporting internal activities related to medical communications, medical information and clinical research. This position reports to the Director, MSL Team and is field based with a corporate headquarters in Emeryville, California.

Responsibilities:

Provides project leadership and management on field team and functional area initiatives;

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Clinical Research Associate

The Senior Clinical Research Associate (Sr. CRA) will be responsible for ensuring high quality execution of single and multi-site clinical studies, across all Phases, according to the protocols, while adhering to GCP/ICH, and to Adamas Pharmaceutical Inc. SOPs within reasonable limits of time and budget. Reports to the Director, Clinical Operations.

Responsibilities:

Coordinate & perform comprehensive site management across the life of the study

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Counsel, Healthcare Law

The Senior Counsel, Healthcare Law, will support legal matters related to the strategy and execution of commercial, medical, and clinical activities. This position reports to the Assistant General Counsel and is expected to work closely with other members of the legal and compliance group, as well as executive, commercial, medical, regulatory, and clinical teams. This position is based in Emeryville, CA.

Responsibilities:

Serves as a strategic business partner across the organization by providing legal support and counsel related to sales and marketing activities, medical affairs, and clinical development;

Acts as lead counsel for one or more pharmaceutical brands, including participation in cross-functional committees charged with developing strategies and reviewing promotional and scientific communications;

Works collaboratively across a broad range of functions developing and maintaining effective working relationships to facilitate a team-based approach to meeting corporate objectives.

Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.

Qualifications:

Juris Doctorate required and state bar license;

At least six (6) years of experience with a healthcare-related law firm or as part of a biotechnology or pharmaceutical company’s legal department (a combination of private practice and in-house experience preferred);

Experience advising clients on commercial and scientific activities related to an FDA-approved product and pipeline products, including participation in cross-functional review committees;

Ability to understand the strategic and tactical objectives of the business and provide regulatory, transactional, and general legal support as needed;

Must have excellent business judgment, people and management skills, and be a collaborative team player;

Successful experience in a fast-paced entrepreneurial environment;

Fit with Adamas’ culture and values.

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.

Senior Manager, Pre-commercial Quality Assurance

The Senior Manager, Pre-commercial Quality Assurance is responsible for managing quality operations at Adamas Contract Service Providers of clinical drug substance, drug product, packagers and distribution to ensure that CSP are in compliance with applicable regulations, Quality Agreements (QA), and Standard Operating Procedures (SOP’s). In addition will provide Quality support to all Development Project Teams. This position will report to the Vice President of Quality Assurance and is based in Emeryville, CA.

Ensures that performance and quality of clinical supply materials providers conform to established standards and regulatory agencies requirements;

Responsible for ensuring that quality data is collected and that the rights and well-being of the clinical trial subjects are protected Primary person for the quality oversight of clinical trial material / investigation medicinal products release to distribution including master batch record review and approval, executed batch record review, assessment of deviations, change control and analytical data for the disposition of product in support of regulatory applications and release in IRT for clinical use;

Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies in support of regulatory applications and to assure compliance in all product to be used for clinical purposes;

Works directly with clinical product suppliers in conjunction with the Adamas Clinical Supplies Manager to ensure operations remain in a compliant state, and product meets all required standards and specifications;

Quality oversight responsibilities for all aspects of manufacturing, packaging, labelling, and kitting of drug product intended for use in clinical trials; including scheduled material of product to be used for clinical purposes;

Leads external quality audits for the qualification of developmental and clinical contract service providers;

Supports Adamas during audits and inspections to sites responsible for the handling of product to be used in support of regulatory submissions and in clinical studies;

Provides quality support for the development and maintenance of clinical trial protocols, clinical trial master files, clinical study reports, as well as clinical site qualification and monitoring;

Responsible to support in the Regulatory submissions of New Drug Applications (NDA)

Complies with corporate policies and procedures, as well as, US healthcare laws and regulations.

Qualifications:

Bachelor’s degree in science or related field and + 8 years of relevant hands on experience in a highly regulated pre-commercial environment;

Experience in the all aspects of manufacturing, packaging, labelling, kitting, and distribution of oral solid dosage drug product intended for use in clinical trials; including scheduled material of product to be used for clinical purposes;

Ability to understand / implement written and verbal instructions to all levels in the organization;

High level of professionalism and collaboration in team and sub-teams settings;

Extensive experience working successfully with oral solid dosage developmental and clinical contract service providers, and ensuring that regulatory standards and timelines are consistently met;

Ability to travel 40-50% of the time depending on business needs;

Successful experience in fast-paced entrepreneurial environment;

Fit with Adamas culture and values

To apply for this position please send your resume to hr@adamaspharma.com with the job title in the subject line. Principals only, no recruiters please.

Adamas is an Equal Opportunity Employer

The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.